A Cluster Randomized Controlled Trial to Evaluate the Effectiveness of an Educational Toolkit Among Poor Communities in Improving Vaccination Confidence in the Philippines

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This cluster randomized controlled trial (RCT) aims to evaluate the feasibility and efficacy of an educational toolkit in enhancing measles, mumps, rubella (MMR) and polio vaccine confidence in the Philippines. The toolkit contains four aspects: an introduction to MMR and polio vaccines, vaccine safety and efficacy, vaccination guidelines (including schedules and locations), and debunking myths and misconceptions. Presented as a 10-minute video and followed by reminder messages from health educators, the toolkit was developed in collaboration with International Care Ministries (ICM) health educators and translated into local dialects. Our toolkit will be embedded in a RCT called the Soap Opera Trial, which is designed and run by the ICM leveraging their community-based Transform Program. The standard Transform Program consists of 15 weeks of education sessions delivered by local health educators through traditional lectures in each community. The trial aims to evaluate the impact of a variation to their standard Transform Program, which uses aspirational videos to deliver education about food security, livelihood, and health. The soap opera to be shown in the video includes drama and plot twists similar to a typical television show but highlights lessons about income creation, health care, and resilience, which are key behaviors and outcomes that can help the poor lift themselves out of poverty. The ICM will conduct this RCT to assess the impact of these soap opera videos on outcomes such as aspirations about the future. A total of 180 communities participating in the Transform program will be randomly assigned to one of the two arms. In the intervention arm, the participants will receive our vaccine toolkit intervention (including educational video and reminding messages about MMR and polio vaccines) and 15 soap opera videos alongside standard Transform Program, while participants in the control arm will receive the standard Transform Program, in which the education sessions are delivered through lectures. The effectiveness of the toolkit will be evaluated by 1) the rate of MMR and polio vaccination among children of the Transform Program participants and 2) knowledge and attitudes towards these vaccines among the participants. Additionally, the relevance, applicability, and feasibility of the toolkit will be assessed using qualitative research methods, and cost-effectiveness of the intervention will be assessed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Individuals reside in the participating communities where ICM recruits for the Transform Program.

• Individuals meet the criteria and definition of ultra-poor based on the ICM's screening\*.

• Individuals give oral informed consent to participate in the health education sessions which includes the delivery of our toolkit. There must be 30 eligible participants before a community will be approved to participate in the ICM Transform Program.

⁃ All participating communities of the ICM Soap Opera trial who provided consents to health education sessions will be eligible to participate in the vaccine confidence trial. Participants will be screened using a poverty score card, loosely based on the Progress out of Poverty Index (PPI) developed for the Philippines (Innovations for Poverty Action, 2014) and self-reported household income. Participants in households that meet the definition of ultra-poor by income (\< 22 Philippine pesos per person per day) are prioritized to be recruited for the Transform Program.

Locations
Other Locations
Philippines
International Care Ministries
RECRUITING
Manila
Contact Information
Primary
Shishi Wu, PhD
shishi.wu@utoronto.ca
+1 6047823674
Backup
Xiaolin Wei, PhD
xiaolin.wei@utoronto.ca
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2025-02-25
Participants
Target number of participants: 5400
Treatments
Experimental: Intervention
Participants in the intervention arm will receive our vaccine toolkit intervention, which includes two main components: 1) our educational toolkit on MMR and polio vaccination in the form of a video, which will be introduced and presented to the participants from Week 12 to Week 15 of the Transform program, 2) reminding messages regarding vaccination, which will be delivered following the video session and embedded in Saving Groups program run in the communities. Additionally, participants in the intervention arm will also receive a series of 15 soap opera videos, one for each week, to complement the 15-week Transform Program's education session, which is the core intervention of the Soap Opera Trial developed and run by the ICM.
No_intervention: Control
In the control group, participants will attend the standard 15-week Transform program, with education sessions delivered through traditional lectures by health educators from ICM on the topics of income creation, education, food security, and resilience. Our educational toolkit of MMR and polio vaccination will not be provided and there will be no specific reminders or discussions regarding MMR and polio vaccinations.
Sponsors
Leads: University of Toronto
Collaborators: International Care Ministries, the Philippines

This content was sourced from clinicaltrials.gov